Lymphoma Receiving CAR-T TherapyFMTNCT07509450
Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cell Transplant: A Pilot Study
A study testing Fecal Microbial Transplant Enema in people with Lymphoma Receiving CAR-T Therapy, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a single site pilot trial will evaluate the feasibility and safety of fecal microbiota transplantation (FMT) in patients with B-cell lymphoma who are undergoing CAR-T or in patients with moderate to high-risk acute myeloid leukemia or myelodysplastic syndrome who are undergoing allogeneic stem cell… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma Receiving CAR-T Therapy
- What is being tested?
- Fecal Microbial Transplant Enema
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jun 2026to 2 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 years of age
- Diagnosis of the following:
- Indolent or aggressive B-cell lymphoma eligible for standard or care CAR-T therapy (Cohort A), or
- Patients with AML or high risk MDS with indication to undergo reduced-intensity conditioning alloSCT, with an available matched related, unrelated, or haploidentical donor (Cohort B)
- ECOG 0-1
- Adequate marrow function defined by:
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- Hemoglobin >80 g/L without transfusion dependence within the last 7 days
- Platelet count >20 x 109/L without transfusion dependence within the last 7 days
- Neutrophil count >1.0 x 109/L without growth factor support within the last 7 days
- Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin < 1.5 x ULN (unless documented Gilbert's syndrome)
- Adequate renal function as defined as creatinine clearance ≥ 30 mL/min directly measured with a 24-hour urine collection or calculated according to the modified formula of Cockcroft-Gault equation or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) calculation
- Life expectancy >6 months
- Women of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and up to 6 months after the last dose of protocol therapy. Men who are sexually active must use highly effective methods of contraception during treatment and up to 6 months after the last dose of protocol therapy. Men require an agreement to remain abstinent (ie, refrain from heterosexual intercourse) or use a condom, and an agreement to refrain from donating sperm. Periodic abstinence and withdrawal are not acceptable methods of contraception. Fertility preservation options should be discussed. Examples of highly effective contraceptive methods include an agreement to remain abstinent (ie, refrain from heterosexual intercourse), bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
- Willing and able to participate in all required evaluations and procedures in this study.
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- For patients undergoing alloSCT (Cohort B): plan to undergo myeloablative conditioning
- Use of investigational agents within the last 4 weeks before enrollment.
- Active or uncontrolled infection
- Autoimmune disorder currently being treated with disease-modifying therapy or with >10mg/day prednisone
- Inflammatory bowel disease
- History of intestinal perforation
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- Gastrointestinal surgical procedure within the past 4 weeks before enrollment
- Pregnant or breast-feeding patients
- HIV infection with detectable viral load or CD4 count <200
- Serologic status reflecting active hepatitis B or C infection as follows:
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA. (Note, patients with undetectable HBV DNA are permitted to enroll if they are on Hepatitis B suppressive therapy)
- Patients with presence of hepatitis C virus (HCV) antibody and HCV RNA detectable
- History of infection or known colonization with antibiotic resistant organism in the last two years before enrollment (including ESBL, MRSA, VISA, VRSA, VRE, CPE)
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2M9
Abi Vijenthira, MD, 416-946-4501 ext. 3377, Abi.Vijenthira@uhn.ca
About this study
This is a single site pilot trial will evaluate the feasibility and safety of fecal microbiota transplantation (FMT) in patients with B-cell lymphoma who are undergoing CAR-T or in patients with moderate to high-risk acute myeloid leukemia or myelodysplastic syndrome who are undergoing allogeneic stem cell transplantation.
Read the detailed description
This is a single centre, non-randomized, single-arm interventional pilot study examining fecal microbiota transplantation in patients undergoing CAR-T or allogeneic stem cell transplantation (alloSCT). 20 eligible patients will be enrolled in this study 10 patients with B-cell lymphoma undergoing CAR-T and 10 patients with AML/MDS undergoing alloSCT. FMT series occurring prior to cellular therapy and 30 days after cellular therapy treatment. Standard of care blood tests including HIV, Hepatitis B and C testing, pregnancy test and physical exam will be done during the study. Blood, urine, rectal swab, stool sample will be collected for correlative studies. Patients will be asked to complete a questionnaire questionnaire on perceptions and acceptability of FMT. The total study duration will be approximately 2.5 years, including 2 years of recruitment, minimum 1 series of FMT treatments and a minimum 6 months of follow-up.
- Conditions
- Lymphoma Receiving CAR-T Therapy
- Being tested
- Fecal Microbial Transplant Enema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbial Transplant EnemaBiological
Rectal infusion of FMT will be administered every 48 hours for 2 doses, on 2 separate occasions, detailed in the study calendar. For each series of FMT administrations, the first dose will be 100g and the second will be 50g. Each FMT will be delivered using a single dose (300 ml of prepared fecal filtrate containing 100g or 50g of stool from a donor) delivered using an enema bag and rectal catheter. The procedure, including preparation steps, will take less than 20 - 30 minutes.
The second FMT administration will occur in either the inpatient or outpatient setting depending on whether the patient has been discharged from hospital by the time their second FMT series is due at Day +30. The second FMT series will only occur if patients have a neutrophil count of ANC>1.0 x 109/L without growth factor support for the last 7 days, documented within 7 days prior to the FMT administration.
Fecal Microbial Transplant EnemaBiological
Rectal infusion of FMT will be administered every 48 hours for 2 doses, on 2 separate occasions, detailed in the study calendar. For each series of FMT administrations, the first dose will be 100g and the second will be 50g. Each FMT will be delivered using a single dose (300 ml of prepared fecal filtrate containing 100g or 50g of stool from a donor) delivered using an enema bag and rectal catheter. The procedure, including preparation steps, will take less than 20 - 30 minutes.
The second FMT administration will occur in either the inpatient or outpatient setting depending on whether the patient has been discharged from hospital by the time their second FMT series is due at Day +30. The second FMT series will only occur if patients have a neutrophil count of ANC>1.0 x 109/L without growth factor support for the last 7 days, documented within 7 days prior to the FMT administration.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T cell transplant | Experimental | Patients will receive Fecal microbiota transplantation and CAR-T cell infusion Receives: Biological: Fecal Microbial Transplant Enema |
| Allogenic stem cell transplant | Experimental | Patients will receive Fecal microbiota transplantation and allogenic cell trnsplant Receives: Biological: Fecal Microbial Transplant Enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility of fecal microbiota transplantation (FMT) in patients undergoing CAR-T or allogeneic stem cell transplantation.
The study hypothesizes successful recruitment of at least 50% of approached patients, retain at least 80% of patients on the study, and successfully administer at least one FMT series to 80% of retained patients.
Measured: 2.5 years
To evaluate the safety of fecal microbiota transplantation (FMT) in patients undergoing CAR-T or allogeneic stem cell transplantation.
The study hypothesizes that FMT will be safe in this population. Each cohort will be considered separately in considering the differing risks of CAR-T and alloSCT. The study hypothesizes that in each cohort there will be no greater than 10% incidence (N< 1 of 10 participants in each cohort), of serious adverse events, or Grade >3 adverse events of special interest (sepsis and/or bacteremia, ICU admission, bowel perforation, or death) within 48 hours of administration of FMT, which are judged to be possibly, probably or definitely related to FMT.
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start2 Jun 2026
- Primary completion2 Jun 2029 (estimated)
- Study completion2 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma Receiving CAR-T TherapyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There will be 2 cohorts run parallely. Both cohorts patients will receive fecal microbiota transplantation (FMT). One cohort will receive stem cell transplant and the other one will receive CAR-T infusion.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509450
- Sponsor's protocol ID
- FMT Pilot Study
- Other IDs
- OZUHN-038
- Acronym
- FMT
- Status last verified
- Jul 2026
- First submitted
- 10 Mar 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cell Transplant: A Pilot Study
- ClinicalTrials.gov ID
- NCT07509450
- Acronym / sponsor ID
- FMT / FMT Pilot Study
- Conditions
- Lymphoma Receiving CAR-T Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 2 Jun 2029 (estimated)
- Study completion
- 2 Jun 2029 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single site pilot trial will evaluate the feasibility and safety of fecal microbiota transplantation (FMT) in patients with B-cell lymphoma who are undergoing CAR-T or in patients with moderate to high-risk acute myeloid leukemia or myelodysplastic syndrome who are undergoing allogeneic stem cell transplantation.
Detailed description
This is a single centre, non-randomized, single-arm interventional pilot study examining fecal microbiota transplantation in patients undergoing CAR-T or allogeneic stem cell transplantation (alloSCT). 20 eligible patients will be enrolled in this study 10 patients with B-cell lymphoma undergoing CAR-T and 10 patients with AML/MDS undergoing alloSCT. FMT series occurring prior to cellular therapy and 30 days after cellular therapy treatment. Standard of care blood tests including HIV, Hepatitis B and C testing, pregnancy test and physical exam will be done during the study. Blood, urine, rectal swab, stool sample will be collected for correlative studies. Patients will be asked to complete a questionnaire questionnaire on perceptions and acceptability of FMT. The total study duration will be approximately 2.5 years, including 2 years of recruitment, minimum 1 series of FMT treatments and a minimum 6 months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be 2 cohorts run parallely. Both cohorts patients will receive fecal microbiota transplantation (FMT). One cohort will receive stem cell transplant and the other one will receive CAR-T infusion.
| Arm | Type | Receives |
|---|---|---|
| CAR-T cell transplant | Experimental | Biological: Fecal Microbial Transplant EnemaPatients will receive Fecal microbiota transplantation and CAR-T cell infusion |
| Allogenic stem cell transplant | Experimental | Biological: Fecal Microbial Transplant EnemaPatients will receive Fecal microbiota transplantation and allogenic cell trnsplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Men and women ≥ 18 years of age
- Diagnosis of the following:
- ECOG 0-1
- Adequate marrow function defined by:
- Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin < 1.5 x ULN (unless documented Gilbert's syndrome)
Key exclusion criteria (14 listed)
- For patients undergoing alloSCT (Cohort B): plan to undergo myeloablative conditioning
- Use of investigational agents within the last 4 weeks before enrollment.
- Active or uncontrolled infection
- Autoimmune disorder currently being treated with disease-modifying therapy or with >10mg/day prednisone
- Inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbial Transplant EnemaRectal infusion of FMT will be administered every 48 hours for 2 doses, on 2 separate occasions, detailed in the study calendar. For each series of FMT administrations, the first dose will be 100g and the second will be 50g. Each FMT will be delivered using a single dose (300 ml of prepared fecal filtrate containing 100g or 50g of stool from a donor) delivered using an enema bag and rectal catheter. The procedure, including preparation steps, will take less than 20 - 30 minutes. The second FMT administration will occur in either the inpatient or outpatient setting depending on whether the patient has been discharged from hospital by the time their second FMT series is due at Day +30. The second FMT series will only occur if patients have a neutrophil count of ANC>1.0 x 109/L without growth factor support for the last 7 days, documented within 7 days prior to the FMT administration. | Biological | Allogenic stem cell transplant |
| Fecal Microbial Transplant EnemaRectal infusion of FMT will be administered every 48 hours for 2 doses, on 2 separate occasions, detailed in the study calendar. For each series of FMT administrations, the first dose will be 100g and the second will be 50g. Each FMT will be delivered using a single dose (300 ml of prepared fecal filtrate containing 100g or 50g of stool from a donor) delivered using an enema bag and rectal catheter. The procedure, including preparation steps, will take less than 20 - 30 minutes. The second FMT administration will occur in either the inpatient or outpatient setting depending on whether the patient has been discharged from hospital by the time their second FMT series is due at Day +30. The second FMT series will only occur if patients have a neutrophil count of ANC>1.0 x 109/L without growth factor support for the last 7 days, documented within 7 days prior to the FMT administration. | Biological | CAR-T cell transplant |
Primary outcome
To evaluate the feasibility of fecal microbiota transplantation (FMT) in patients undergoing CAR-T or allogeneic stem cell transplantation.
Time frame: 2.5 years
The study hypothesizes successful recruitment of at least 50% of approached patients, retain at least 80% of patients on the study, and successfully administer at least one FMT series to 80% of retained patients.
To evaluate the safety of fecal microbiota transplantation (FMT) in patients undergoing CAR-T or allogeneic stem cell transplantation.
Time frame: 2.5 years
The study hypothesizes that FMT will be safe in this population. Each cohort will be considered separately in considering the differing risks of CAR-T and alloSCT. The study hypothesizes that in each cohort there will be no greater than 10% incidence (N< 1 of 10 participants in each cohort), of serious adverse events, or Grade >3 adverse events of special interest (sepsis and/or bacteremia, ICU admission, bowel perforation, or death) within 48 hours of administration of FMT, which are judged to be possibly, probably or definitely related to FMT.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbial Transplant Enema in people with Lymphoma Receiving CAR-T Therapy, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abi Vijenthira, MD (416-946-4501 ext. 3377, Abi.Vijenthira@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the feasibility of fecal microbiota transplantation (FMT) in patients undergoing CAR-T or allogeneic stem cell transplantation. (time frame: 2.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.